REGULATORY

• J&J’s Opsumit Designated as Drug for Specific Use: MHLW
  April 1, 2025

• Japan Jittery over Mass Layoffs at FDA, though HHS Says Reviewers Won’t Be Affected
  March 31, 2025

• Label Updated for Eliquis, Imbruvica, and Brimonidine: PMDA
  March 31, 2025

• MHLW Flags Risk of Eye Disorders Associated with Tivdak upon Approval
  March 31, 2025

• Daisuke Koga Named Head of PMDA’s International Office
  March 31, 2025

• AMED Ties Up with Korea’s Govt Backed Research Institute
  March 31, 2025

• Sakigake Tag Withdrawn for Boehringer, AbbVie APIs
  March 31, 2025

• Nitrosamine Detected in Sumitomo’s Arotinolol, but No Recall Planned
  March 28, 2025

• Choseido’s Kawauchi Plant Suspended for 1 Month on GMP Violation
  March 28, 2025

• Japan Approves J&J’s Lazcluze, Genmab’s Tivdak, and More
  March 28, 2025

• Japan Won’t Ban Red No. 3 for Now but Asks Industry for Self-Inspections
  March 27, 2025

• It’s Time to Review Conditional Approval System for Regenerative Medicines: MHLW Official
  March 27, 2025

• PMDA Stepping Up Efforts to Woo Overseas Startups to Japan
  March 27, 2025

• MHLW Presents Expected Roles of Clinical Research Hospitals towards Criteria Review
  March 26, 2025

• Raise Deduction Cap for Self-Medication Tax Break: OTC Industry Chief
  March 26, 2025

• NCC President Nakagama to Lead AMED from April
  March 26, 2025

• Pariet’s Nonprescription Versions Approved 6 Years after Discussions Start
  March 25, 2025

• AMED President Mishima Hints at Resignation
  March 25, 2025

• FPMAJ Prods Drastic Review of Fiscal Framework before Honebuto 2025
  March 25, 2025

• Difficult to “Visualize” Distribution, Production Costs in NHI Prices: Minister
  March 25, 2025

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